FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
74281–74304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 2002
HYDROBOOT
K022233 · DWL
Incappe, Inc.
General Hospital · 33d
Cleared Aug 12, 2002
EBI XFIX DFS SYSTEM
K022319 · KTT
Ebi, L.P.
Orthopedic · 26d
Cleared Aug 12, 2002
MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE
K022405 · GZJ
Rehabilicare, Inc.
Neurology · 27d
Cleared Aug 12, 2002
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K022419 · KWQ
Ebi, L.P.
Orthopedic · 19d
Cleared Aug 12, 2002
RAPID-FILL TUBESET, MODEL 90005
K022523 · LHI
Baxa Corp.
General Hospital · 13d
Cleared Aug 12, 2002
HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
K022546 · EOQ
Horizons Intl. Corp.
Ear, Nose, Throat · 11d
Cleared Aug 09, 2002
FLEXLINE CLAMP
K010727 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 515d
Cleared Aug 09, 2002
LUMENIS SELECTA DUET
K021550 · GEX
Ellex Medical Pty, Ltd.
General & Plastic Surgery · 88d
Cleared Aug 09, 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
K021556 · HWC
Synthes (Usa)
Orthopedic · 88d
Cleared Aug 09, 2002
NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE
K021578 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 87d
Cleared Aug 09, 2002
MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM
K021579 · HWC
Magly Orthopedics, LLC
Orthopedic · 87d
Cleared Aug 09, 2002
DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE
K022095 · LZA
Wilshire Technologies
General Hospital · 43d
Cleared Aug 09, 2002
GIVEN DIAGNOSTICS SYSTEM
K022362 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 18d
Cleared Aug 08, 2002
URETERAL STENT
K013784 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 267d
Cleared Aug 08, 2002
BOYD DELIVERY UNIT
K020833 · EIA
Boyd Industries, Inc.
Dental · 147d
Cleared Aug 08, 2002
QUANTIM 16 AUTOCLAVE
K021064 · FLE
Scican
General Hospital · 128d
Cleared Aug 08, 2002
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K021143 · LPN
Alcon Universal, Ltd.
Ophthalmic · 121d
Cleared Aug 08, 2002
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
K021538 · HQF
Lightmed Corp.
Ophthalmic · 90d
Cleared Aug 08, 2002
OSA RIGID INTERNAL FIXATION SYSTEM
K021618 · JEY
Osteomed Corp.
Dental · 84d
Cleared Aug 08, 2002
SHEATH ADAPTER, MODEL SA-09847
K021723 · DYB
Arrow Intl., Inc.
Cardiovascular · 76d
Cleared Aug 08, 2002
ADAPT OPEN ACCESS PORT, MODEL 41233
K021731 · GCJ
Taut, Inc.
General & Plastic Surgery · 76d
Cleared Aug 08, 2002
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
K021735 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 72d
Cleared Aug 08, 2002
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
K022107 · DRN
Cardiomedics, Inc.
Cardiovascular · 41d
Cleared Aug 08, 2002
LAMITRODE S-SERIES (S4 AND S8) LEADS
K022222 · GZB
Advanced Neuromodulation System,Inc
Neurology · 30d